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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: DHR FDA class 2

    System, Test, Rheumatoid Factor

    Immunology

    View full classification →

    The Rheumatoid Factor Test System is a diagnostic assay used to detect and quantify rheumatoid factor, an autoantibody directed against IgG, in patient serum or plasma, supporting the diagnosis of rheumatoid arthritis and other autoimmune conditions. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5775 within the Immunology specialty. The device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
    QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
    EliA RF IgM Immunoassay
    Optilite Rheumatoid Factor Kit
    Rheumatoid Factor (RF) Kit for use on SPAPLUS
    ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
    RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
    ORGENTEC RHEUMATOID FACTOR EIA
    IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
    N LATEX RF KIT
    OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
    MININEPH HUMAN RHEUMATOID FACTOR KIT
    VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
    ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
    MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
    RHEUMATOID FACTOR (RF)
    WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
    DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
    TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
    COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
    AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
    AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
    MDI RF TEST
    AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
    K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
    K-ASSAY RHEUMATOID FACTOR
    ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
    RF
    RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
    THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
    QUANTA LITE RF IGG ELISA
    QUANTA LITE RF IGA ELISA
    COLOR-SLIDE RF
    DIAMEDIX IS-RF TEST SYSTEM
    RAPET RF
    RHEUMACOL RHEUMATOID FACTOR TEST
    QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
    RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
    ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
    QUANTA LITE RF IGM
    TINAQUANT RHEUMATOID FACTOR ASSAY
    SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
    RAICHEM RHEUMATOID FACTOR SPIA
    HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
    THERATEST EL-RFSCR
    N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
    N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
    RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
    IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
    QUALITROL RF CONTROLS

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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